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| Name | Class |
|---|---|
| Integra LifeSciences Corporation | INDUSTRY |
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Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data.
Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SurgiMend Mesh | Other | SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SurgiMend Mesh | Device | Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Rate | Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL. | 6 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Using GERD-HRQL Scale | GERD-HRQL was developed to measure the typical symptoms of GERD and the effect on a patient's quality of life. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. Total score is calculated by summing the individual scores to questions 1-15 with greatest possible score (worst symptoms) = 75 and lowest possible score (no symptoms) = 0. The total score is made up of two sub scores which addressed heartburn and regurgitation symptoms and are reported separately in a heartburn score and regurgitation score as well as the total GERD-HRQL score. The follow up scores were combined due to some participants not having specific follow up information. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Levy, DO | Kettering Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kettering Health Network - Grandview Medical Center | Dayton | Ohio | 45405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23793804 | Background | Furnee E, Hazebroek E. Mesh in laparoscopic large hiatal hernia repair: a systematic review of the literature. Surg Endosc. 2013 Nov;27(11):3998-4008. doi: 10.1007/s00464-013-3036-y. Epub 2013 Jun 21. | |
| 25785415 | Background | Lidor AO, Steele KE, Stem M, Fleming RM, Schweitzer MA, Marohn MR. Long-term quality of life and risk factors for recurrence after laparoscopic repair of paraesophageal hernia. JAMA Surg. 2015 May;150(5):424-31. doi: 10.1001/jamasurg.2015.25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SurgiMend Mesh | SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend Mesh: Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All 9 participants were included in the statistical analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | SurgiMend Mesh | SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend Mesh: Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All 9 participants had the variable age collected and were included in a full cohort analysis. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrence Rate | Recurrence rate will be analyzed by a Upper gastrointestinal tract radiography (UGI) and clinical evaluation in conjunction with patient's reported physiological assessment per the GERD-HRQL. | Due to inconsistent follow-up during the 2020 Pandemic, the investigators used only the 6-month follow up for analysis. | Posted | Count of Participants | Participants | 6 months post surgery |
|
Adverse events were collected from 6 months from the hernia repair surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SurgiMend Mesh | SurgiMend Mesh - FDA approved noncross-linked bovine dermis biologic mesh. SurgiMend Mesh will be used according to FDA approved recommendations for the use of abdominal wall hernia reinforcement. SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. SurgiMend Mesh: Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Levy | Kettering Health | +1(937)531-0195 | paul.levy@ketteringhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2020 | Dec 12, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006551 | Hernia, Hiatal |
| ID | Term |
|---|---|
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
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|
| 6 month post surgery |
| 18841422 | Background | Nason KS, Luketich JD, Qureshi I, Keeley S, Trainor S, Awais O, Shende M, Landreneau RJ, Jobe BA, Pennathur A. Laparoscopic repair of giant paraesophageal hernia results in long-term patient satisfaction and a durable repair. J Gastrointest Surg. 2008 Dec;12(12):2066-75; discussion 2075-7. doi: 10.1007/s11605-008-0712-7. Epub 2008 Oct 8. |
| 25289348 | Background | Adelman DM, Selber JC, Butler CE. Bovine versus Porcine Acellular Dermal Matrix: A Comparison of Mechanical Properties. Plast Reconstr Surg Glob Open. 2014 Jun 6;2(5):e155. doi: 10.1097/GOX.0000000000000072. eCollection 2014 May. |
| 17439596 | Background | Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. doi: 10.1111/j.1442-2050.2007.00658.x. |
| Background | Radiologic Society of North America (2019). Radiation dose in X-Ray and CT Exam. Available at https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray |
| Background | K. S. Silvipriya, K. Krishna Kumar*, A. R. Bhat, B. Dinesh Kumar, Anish John, Panayappan Lakshmanan. Collagen: Animal Sources and Biomedical Application. Journal of Applied Pharmaceutical Science Vol. 5 (03), pp. 123-127, March, 2015. DOI: 10.7324/JAPS.2015.50322 |
| 18656819 | Background | Kahrilas PJ, Kim HC, Pandolfino JE. Approaches to the diagnosis and grading of hiatal hernia. Best Pract Res Clin Gastroenterol. 2008;22(4):601-16. doi: 10.1016/j.bpg.2007.12.007. |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Categorical variable for gender, female & male | All 9 participants had the variable age collected and were included in a full cohort analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| GERD-HRQL survey | a validated 15-item questionnaire used to measure the severity of GERD symptoms, ranging from 0 (no symptoms) to 75 (worst possible symptoms) | Mean | Standard Deviation | 0-75 score on survey |
|
|
|
| Secondary | Quality of Life Using GERD-HRQL Scale | GERD-HRQL was developed to measure the typical symptoms of GERD and the effect on a patient's quality of life. Scale is 0-5 with 0 being no symptoms and 5 being symptoms are incapacitating. Total score is calculated by summing the individual scores to questions 1-15 with greatest possible score (worst symptoms) = 75 and lowest possible score (no symptoms) = 0. The total score is made up of two sub scores which addressed heartburn and regurgitation symptoms and are reported separately in a heartburn score and regurgitation score as well as the total GERD-HRQL score. The follow up scores were combined due to some participants not having specific follow up information. | Due to inconsistent follow-up during the 2020 Pandemic, the investigators used only the 6-month follow up for analysis. | Posted | Mean | Standard Deviation | score on a scale | 6 month post surgery |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Total Score |
|